Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

This trial had an adaptive design that pre-specified the closure of the 32 U (units) (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).

This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).

Arm/Group Title

Placebo

Acthar 8 Units

Acthar 16 Units

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Overall Number of Participants Analyzed

8

6

10

Least Squares Mean (Standard Error)

Unit of Measure: percent change

-20.407
(6.0183)

-37.456
(7.8387)

-22.097
(5.4619)

3.Secondary Outcome

Title

Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death

Description

[Not Specified]

Description

[Not Specified]

Time Frame

Visit 12 (Week 36) and Visit 17 (Week 52)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).

Arm/Group Title

Placebo

Acthar 8 Units

Acthar 16 Units

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Overall Number of Participants Analyzed

10

7

16

Measure Type: Count of Participants

Unit of Measure: Participants

Visit 12 (Week 36)

Yes

0

0.0%

1

14.3%

1

6.3%

No

10

100.0%

6

85.7%

15

93.8%

Visit 17 (Week 52)

Yes

0

0.0%

1

14.3%

2

12.5%

No

10

100.0%

6

85.7%

14

87.5%

4.Secondary Outcome

Title

Time to Doubling of Serum Creatinine or ESRD or Death

Description

The frequency doubling of serum creatinine or progression to ESRD or d...

Description

The frequency doubling of serum creatinine or progression to ESRD or death was small therefore this parameter could not be analyzed.

This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).

This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).

Arm/Group Title

Placebo

Acthar 8 Units

Acthar 16 Units

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Overall Number of Participants Analyzed

9

3

8

Mean (Standard Deviation)

Unit of Measure: percent change

Visit 12 (Week 36)

Number Analyzed

9 participants

3 participants

8 participants

-14.25
(17.155)

-11.49
(10.334)

-10.24
(22.066)

Visit 17 (Week 52)

Number Analyzed

6 participants

2 participants

8 participants

1.14
(21.155)

-35.90
(1.509)

-12.43
(20.522)

7.Secondary Outcome

Title

Percent Change From Baseline in eGFR by Visit

Description

Percent change from baseline in eGFR by visit

Description

Percent change from baseline in eGFR by visit

Time Frame

Visit 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).

Arm/Group Title

Placebo

Acthar 8 Units

Acthar 16 Units

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Overall Number of Participants Analyzed

10

7

16

Mean (Standard Deviation)

Unit of Measure: percent change

Baseline to Visit 3

Number Analyzed

9 participants

7 participants

14 participants

-6.19
(16.494)

1.82
(11.347)

0.86
(11.659)

Baseline to Visit 4

Number Analyzed

10 participants

7 participants

14 participants

-11.76
(14.131)

4.39
(9.133)

-2.69
(11.252)

Baseline to Visit 5

Number Analyzed

10 participants

5 participants

12 participants

-8.42
(14.942)

-10.11
(9.614)

-12.01
(14.395)

Baseline to Visit 6

Number Analyzed

9 participants

5 participants

11 participants

-12.73
(8.881)

-9.36
(14.723)

-14.20
(16.300)

Baseline to Visit 7

Number Analyzed

9 participants

5 participants

11 participants

-12.30
(6.888)

-25.42
(10.079)

-17.33
(21.629)

Baseline to Visit 8

Number Analyzed

8 participants

3 participants

10 participants

-11.64
(6.539)

-27.46
(11.435)

-17.58
(23.071)

Baseline to Visit 9

Number Analyzed

9 participants

3 participants

10 participants

-14.46
(8.535)

-21.04
(8.414)

-23.25
(18.344)

Baseline to Visit 10

Number Analyzed

8 participants

3 participants

8 participants

-15.75
(10.914)

-28.73
(6.789)

-20.57
(23.747)

Baseline to Visit 11

Number Analyzed

9 participants

3 participants

8 participants

-14.71
(12.052)

-26.13
(3.041)

-19.05
(20.996)

Baseline to Visit 12

Number Analyzed

9 participants

3 participants

8 participants

-26.09
(11.687)

-23.54
(7.853)

-18.32
(22.929)

Baseline to Week 36 Endpoint

Number Analyzed

10 participants

7 participants

16 participants

-24.96
(11.581)

-20.27
(15.818)

-17.55
(19.655)

Baseline to Visit 13

Number Analyzed

8 participants

3 participants

7 participants

-17.94
(14.297)

-29.37
(10.193)

-23.46
(25.490)

Baseline to Visit 14

Number Analyzed

8 participants

2 participants

8 participants

-21.88
(11.695)

-33.99
(20.993)

-29.96
(18.970)

Baseline to Visit 15

Number Analyzed

7 participants

2 participants

7 participants

-17.40
(14.334)

-38.05
(8.677)

-19.95
(18.899)

Baseline to Visit 16

Number Analyzed

5 participants

2 participants

8 participants

-19.16
(18.686)

-40.18
(5.668)

-27.33
(16.709)

Baseline to Visit 17

Number Analyzed

6 participants

2 participants

8 participants

-18.43
(12.893)

-42.70
(15.255)

-24.55
(22.322)

Baseline to Week 52 Endpoint

Number Analyzed

8 participants

6 participants

10 participants

-20.69
(12.433)

-36.50
(11.573)

-22.44
(20.669)

8.Secondary Outcome

Title

Percent Change From Baseline in Protein to Creatinine Ratio (PCR)

Description

Percent change from baseline in PCR

Description

Percent change from baseline in PCR

Time Frame

Visits 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).

Arm/Group Title

Placebo

Acthar 8 Units

Acthar 16 Units

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Overall Number of Participants Analyzed

10

7

16

Mean (Standard Error)

Unit of Measure: percent change

Baseline to Visit 4

Number Analyzed

9 participants

6 participants

14 participants

0.3837
(31.26202)

44.7508
(78.75623)

32.5701
(71.34201)

Baseline to Visit 5

Number Analyzed

10 participants

5 participants

10 participants

-13.6630
(25.57771)

47.4429
(54.03221)

2.0594
(59.12062)

Baseline to Visit 6

Number Analyzed

9 participants

5 participants

8 participants

-8.3326
(36.44142)

72.1740
(85.20350)

-1.6086
(47.69994)

Baseline to Visit 7

Number Analyzed

9 participants

5 participants

9 participants

2.4621
(43.42213)

55.9950
(42.92855)

-10.6879
(50.13402)

Baseline to Visit 8

Number Analyzed

8 participants

3 participants

10 participants

12.6601
(51.03925)

53.2134
(43.68087)

-8.5381
(65.06657)

Baseline to Visit 9

Number Analyzed

9 participants

3 participants

9 participants

27.1483
(60.72960)

82.7319
(67.83831)

3.6409
(54.51979)

Baseline to Visit 10

Number Analyzed

8 participants

1 participants

7 participants

8.2594
(45.36335)

18.9898

-6.7500
(64.47765)

Baseline to Visit 11

Number Analyzed

8 participants

3 participants

7 participants

15.1205
(92.21718)

69.8646
(63.88789)

0.4566
(71.78576)

Baseline to Visit 12

Number Analyzed

9 participants

3 participants

8 participants

21.3540
(98.45289)

59.8357
(55.64981)

14.4619
(66.58000)

Baseline to Week 36 Endpoint

Number Analyzed

10 participants

7 participants

16 participants

19.1847
(93.07542)

34.8848
(25.06961)

50.2732
(85.87435)

Baseline to Visit 14

Number Analyzed

8 participants

2 participants

8 participants

1.1894
(44.40008)

11.7663
(5.63288)

-16.4956
(52.71778)

Baseline to Visit 15

Number Analyzed

7 participants

2 participants

7 participants

0.6294
(34.89553)

4.3807
(6.70067)

0.0091
(81.37129)

Baseline to Visit 16

Number Analyzed

6 participants

1 participants

8 participants

0.0025
(47.25812)

21.7536

3.6555
(74.40718)

Baseline to Visit 17

Number Analyzed

6 participants

2 participants

8 participants

20.8644
(88.18113)

19.1625
(40.46023)

-6.2356
(72.81798)

Baseline to Week 52 Endpoint

Number Analyzed

8 participants

6 participants

9 participants

32.9735
(78.62621)

66.7698
(84.63637)

12.1049
(87.56153)

9.Secondary Outcome

Title

Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria

Description

Proportion of subjects whose best response was complete remission (PCR...

Description

Proportion of subjects whose best response was complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of >50% from baseline, plus PCR≤2.5 g/g but >0.5 g/g) of proteinuria

Time Frame

Visit 12 (Week 36) and Visit 17 (Week 52)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).

This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).

Arm/Group Title

Placebo

Acthar 8 Units

Acthar 16 Units

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Arm/Group Description:

Groups 2, 4, 6

Group 1

Groups 3, 5

Overall Number of Participants Analyzed

10

7

16

Mean (Standard Deviation)

Unit of Measure: percent change

Total cholesterol - Baseline to Visit 6

Number Analyzed

9 participants

5 participants

11 participants

-7.2
(8.15)

34.1
(23.94)

10.1
(29.82)

Total cholesterol - Baseline to Visit 9

Number Analyzed

9 participants

3 participants

10 participants

13.9
(22.90)

20.3
(27.82)

14.2
(25.95)

Total cholesterol - Baseline to Visit 12

Number Analyzed

9 participants

3 participants

8 participants

3.4
(22.97)

11.1
(24.57)

11.1
(32.58)

Total cholesterol - Baseline to Week 36 Endpoint

Number Analyzed

10 participants

5 participants

16 participants

3.9
(21.74)

26.4
(28.05)

12.9
(24.22)

Total cholesterol - Baseline to Visit 17

Number Analyzed

6 participants

2 participants

8 participants

6.3
(20.82)

-12.1
(1.57)

9.6
(33.08)

Total cholesterol - Baseline to Week 52 Endpoint

Number Analyzed

6 participants

6 participants

10 participants

6.3
(20.82)

26.8
(45.79)

9.4
(30.28)

Triglycerides - Baseline to Visit 6

Number Analyzed

9 participants

5 participants

11 participants

1.6
(32.24)

30.0
(34.97)

20.5
(58.06)

Triglycerides - Baseline to Visit 9

Number Analyzed

9 participants

3 participants

10 participants

18.4
(34.74)

7.9
(36.59)

31.0
(65.70)

Triglycerides - Baseline to Visit 12

Number Analyzed

9 participants

3 participants

8 participants

8.3
(40.39)

-7.1
(25.12)

29.2
(61.09)

Triglycerides - Baseline to Week 36 Endpoint

Number Analyzed

10 participants

5 participants

16 participants

8.9
(38.12)

48.8
(141.71)

19.9
(38.54)

Triglycerides - Baseline to Visit 17

Number Analyzed

6 participants

2 participants

8 participants

22.6
(62.47)

-37.4
(18.78)

27.7
(63.00)

Triglycerides - Baseline to Week 52 Endpoint

Number Analyzed

6 participants

6 participants

10 participants

22.6
(62.47)

33.5
(76.59)

18.2
(59.15)

LDL-C - Baseline to Visit 6

Number Analyzed

9 participants

5 participants

11 participants

-4.8
(28.04)

47.4
(35.40)

8.1
(42.39)

LDL-C - Baseline to Visit 9

Number Analyzed

9 participants

3 participants

10 participants

16.9
(33.30)

36.1
(50.37)

24.5
(48.65)

LDL-C - Baseline to Visit 12

Number Analyzed

9 participants

3 participants

8 participants

16.0
(45.78)

23.2
(45.40)

26.4
(74.60)

LDL-C - Baseline to Week 36 Endpoint

Number Analyzed

10 participants

5 participants

16 participants

15.9
(43.16)

42.0
(48.66)

12.4
(54.63)

LDL-C - Baseline to Visit 17

Number Analyzed

6 participants

2 participants

8 participants

7.4
(23.12)

-9.9
(12.73)

25.9
(86.13)

LDL-C - Baseline to Week 52 Endpoint

Number Analyzed

6 participants

6 participants

10 participants

7.4
(23.12)

43.2
(66.57)

24.1
(76.69)

HDL-C - Baseline to Visit 6

Number Analyzed

9 participants

5 participants

11 participants

-3.2
(14.03)

11.8
(8.94)

18.1
(35.97)

HDL-C - Baseline to Visit 9

Number Analyzed

9 participants

3 participants

10 participants

0.0
(11.52)

9.8
(4.12)

3.4
(11.34)

HDL-C - Baseline to Visit 12

Number Analyzed

9 participants

3 participants

8 participants

3.7
(26.98)

11.4
(2.70)

-6.9
(13.21)

HDL-C - Baseline to Week 36 Endpoint

Number Analyzed

10 participants

5 participants

16 participants

2.8
(25.59)

6.7
(7.83)

19.0
(58.40)

HDL-C - Baseline to Visit 17

Number Analyzed

6 participants

2 participants

8 participants

-5.0
(7.15)

3.0
(12.26)

-9.2
(15.91)

HDL-C - Baseline to Week 52 Endpoint

Number Analyzed

6 participants

6 participants

10 participants

-5.0
(7.15)

-0.2
(17.50)

-3.2
(21.37)

Lp(a) - Baseline to Visit 6

Number Analyzed

9 participants

5 participants

11 participants

-7.2
(14.30)

35.9
(95.42)

22.7
(41.97)

Lp(a) - Baseline to Visit 9

Number Analyzed

9 participants

3 participants

10 participants

1.9
(20.24)

1.2
(9.32)

28.0
(67.60)

Lp(a) - Baseline to Visit 12

Number Analyzed

9 participants

3 participants

8 participants

6.1
(31.56)

23.3
(20.74)

10.7
(41.39)

Lp(a) - Baseline to Week 36 Endpoint

Number Analyzed

10 participants

5 participants

16 participants

7.5
(30.07)

49.2
(85.05)

16.9
(48.51)

Lp(a) - Baseline to Visit 17

Number Analyzed

6 participants

2 participants

8 participants

28.5
(57.71)

19.9
(24.25)

21.7
(65.09)

Lp(a) - Baseline to Week 52 Endpoint

Number Analyzed

6 participants

6 participants

10 participants

28.5
(57.71)

55.6
(85.65)

21.2
(58.11)

Serum albumin - Baseline to Visit 6

Number Analyzed

9 participants

5 participants

11 participants

-1.92
(4.848)

-9.79
(7.256)

-3.78
(9.721)

Serum albumin - Baseline to Visit 9

Number Analyzed

9 participants

3 participants

10 participants

-2.49
(6.685)

-7.77
(8.638)

-3.75
(10.749)

Serum albumin - Baseline to Visit 12

Number Analyzed

9 participants

3 participants

8 participants

-0.89
(6.798)

-2.67
(14.597)

-4.09
(4.507)

Serum albumin - Baseline to Week 36 Endpoint

Number Analyzed

10 participants

7 participants

16 participants

-1.42
(6.629)

-5.96
(10.357)

-7.23
(6.083)

Serum albumin - Baseline to Visit 17

Number Analyzed

6 participants

2 participants

8 participants

-0.22
(9.002)

8.06
(15.119)

-2.33
(5.898)

Serum albumin - Baseline to Week 52 Endpoint

Number Analyzed

8 participants

6 participants

10 participants

-1.77
(8.822)

-6.15
(14.379)

-2.75
(6.207)

Cortisol - Baseline to Visit 6

Number Analyzed

9 participants

5 participants

11 participants

-5.86
(28.676)

45.08
(151.882)

180.70
(237.206)

Cortisol - Baseline to Visit 9

Number Analyzed

9 participants

3 participants

10 participants

-11.23
(22.791)

14.44
(26.399)

50.08
(135.687)

Cortisol - Baseline to Visit 12

Number Analyzed

9 participants

3 participants

8 participants

-9.44
(39.280)

17.72
(35.704)

52.77
(97.269)

Cortisol - Baseline to Week 36 Endpoint

Number Analyzed

10 participants

7 participants

16 participants

-8.36
(37.189)

63.46
(125.208)

64.32
(187.125)

Cortisol - Baseline to Visit 17

Number Analyzed

6 participants

2 participants

8 participants

-13.11
(31.825)

84.26
(88.861)

7.09
(24.739)

Cortisol - Baseline to Week 52 Endpoint

Number Analyzed

8 participants

6 participants

10 participants

-8.53
(28.727)

51.82
(91.328)

30.21
(89.880)

11.Other Pre-specified Outcome

Title

Change in Mean HbA1c

Description

Change from baseline mean HbA1c (%) to Week 36

Description

Change from baseline mean HbA1c (%) to Week 36

Time Frame

Week 36

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).

Groups 3, 5; This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3). Thus, Adverse Events were not collected separately for these Arms.

Groups 1, 2, 3, 4, 5, 6

All-Cause Mortality

Placebo

Acthar 8 Units

Acthar 16 Units

Overall

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/10 (0.00%)

1/7 (14.29%)

0/17 (0.00%)

1/34 (2.94%)

Serious Adverse Events Serious Adverse Events

Placebo

Acthar 8 Units

Acthar 16 Units

Overall

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

2/10 (20.00%)

1/7 (14.29%)

2/17 (11.76%)

5/34 (14.71%)

Cardiac disorders

Acute myocardial infarction

0/10 (0.00%)

1/7 (14.29%)

0/17 (0.00%)

1/34 (2.94%)

Cardiac failure congestive

0/10 (0.00%)

0/7 (0.00%)

1/17 (5.88%)

1/34 (2.94%)

Gastrointestinal disorders

Gastric antral vascular ectasia

1/10 (10.00%)

0/7 (0.00%)

0/17 (0.00%)

1/34 (2.94%)

Upper gastrointestinal haemorrhage

1/10 (10.00%)

0/7 (0.00%)

0/17 (0.00%)

1/34 (2.94%)

Duodenitis

0/10 (0.00%)

0/7 (0.00%)

1/17 (5.88%)

1/34 (2.94%)

Metabolism and nutrition disorders

Hypoglycaemia

0/10 (0.00%)

0/7 (0.00%)

1/17 (5.88%)

1/34 (2.94%)

Renal and urinary disorders

Acute kidney injury

0/10 (0.00%)

0/7 (0.00%)

1/17 (5.88%)

1/34 (2.94%)

Respiratory, thoracic and mediastinal disorders

Dyspnoea

1/10 (10.00%)

0/7 (0.00%)

0/17 (0.00%)

1/34 (2.94%)

Vascular disorders

Deep vein thrombosis

0/10 (0.00%)

0/7 (0.00%)

1/17 (5.88%)

1/34 (2.94%)

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

A sole participant institution shall not, without Sponsor’s prior written consent, independently publish or otherwise disclose any results of this multicenter study prior to a “multicenter” publication, or 12 months after completion of the study, whichever occurs first. Institution and Principal Investigator shall have the right to publish and present the results of Institution’s and Principal Investigator’s activities solely in accordance with the Sponsor’s written provisions.